Clinical Trials Resource Center

New Medical Therapies™

Respiratory Syncytial Virus (RSV) Infection

August 12, 2013

Novavax released results of a phase I trial of its respiratory syncytial virus (RSV) vaccine candidate in 220 healthy elderly adults (age 60 or older, with a mean age of 68). All subject groups receiving the recombinant fusion (F) protein nanoparticle vaccine candidate exhibited antibody responses against RSV at 28 and 56 days post-immunization, with risesin serum anti-F immunoglobulin G (IgG) antibody levels. Subjects received either 60μg or 90μg of the RSV F vaccine candidate, with or without adjuvant, or a placebo. The overall immune responses were greater in the groups receiving the 90μg dose of RSV F vaccine compared to the groups dosed with 60μg. The 90μg RSV F adjuvanted vaccine group experienced a 5.6-fold rise in anti-F IgG and a sero-response rate of 79% at day 56. Subjects receiving 90μg RSV F vaccine with adjuvant reached levels of competitive antibodies equivalent to 186μg/mL of palivizumab. Levels of antibodies specific for the antigenic site II peptide, representing the neutralizing epitope on the RSV F protein recognized by palivizumab, rose 5.6- to 12.5-fold, with best responses again in the 90μg RSV F adjuvanted vaccine group.

September 24, 2012

Ablynx released results from a phase I trial of ALX-0171 for the treatment of respiratory syncytial virus (RSV) infections. This double-blind, randomized study enrolled 44 healthy males. Subjects received ALX-0171 via nebulizer in six dose levels ranging from 2.1mg to 210mg. A subsequent, multiple dose part was initiated in 16 healthy males, in which the subjects received ALX-0171 140mg or 210mg twice daily for five days. Data showed ALX-0171 could be successfully administered via nebulization directly into the lung in a clinical trial setting, confirming its potential as a first-in-class therapy to treat RSV infections. The stability of the Nanobody make this route of administration possible and provides a potential solution to the pulmonary delivery of biologics where antibodies have been unsuccessful so far. All doses were well tolerated.

October 10, 2011

Novavax issued results from a phase I trial of their respiratory syncytial virus vaccine. The blinded, placebo-controlled, escalating-dose study enrolled 150 healthy adults who were allocated to six cohorts that included four dose levels of vaccine or placebo. The two highest dose levels were formulated with and without an adjuvant. The vaccine was well-tolerated and highly immunogenic. The antibody response to the RSV F protein was significantly increased compared to placebo (p<0.001) in all groups and increased by 19 fold in the highest-dose group at day 60. High rates of seroconversion were seen at all doses, including a rate of 100% at the highest-dose-adjuvant group.

March 10, 2008

Alnylam released positive results from a phase II trial of ALN-RSV01 for the treatment of respiratory syncytial virus (RSV). This double-blind, placebo-controlled study, dubbed GEMINI, enrolled eighty eight adult subjects who were experimentally infected with RSV. The subjects were randomized to receive ALN-RSV01 or placebo, administered intranasally for five consecutive days -- two days prior and three days after viral inoculation. The primary endpoint was efficacy, measured via infection rate, viral dynamics and clinical symptoms. Data revealed that subjects receiving ALN-RSV01 experienced a 38.1% reduction in infection rate as measured by plaque assay (p less than 0.01). Similar reductions in infection rate were obtained with other measurements of viral infection, including RT-qPCR, spin-enhanced culture, and RSV antigen assay. The overall infection rate by any of these measures showed a statistically significant anti-viral effect for ALN-RSV01 (p less than 0.025). Treatment with ALN-RSV01 led to a 95% increase in the number of subjects who remained free of infection compared to placebo; twenty four out of forty three subjects compared to twelve out of forty two subjects, respectively (p less than 0.01). Viral dynamics showed consistent trends favoring an ALN-RSV01 treatment effect, including viral AUC (area under the curve), viral load, peak viral load, duration of viral shedding, and mean daily viral load. There was no significant difference in clinical symptoms. Treatment with ALN-RSV01 was safe and well tolerated. Based on the results, Alnylam plans to commence additional phase II trials in the second half of 2008.

September 3, 2007

MedImmune reported positive results from a phase III trial of motavizumab for the treatment of respiratory syncytial virus (RSV). This randomized, double-blind study enrolled 1,410 full-term infants less than six months of age in two Native American populations. The trial was designed to compare monthly intramuscular injections of motavizumab against placebo in reducing hospitalizations and the incidence of RSV-specific lower respiratory infections (LRIs). Motavizumab was shown to reduce hospitalizations due to RSV by 83% as compared to placebo (8.3 % in placebo arm versus 1.4% in motavizumab; p<0.001). In addition, a 71% reduction in the incidence of RSV-specific LRIs requiring outpatient management (9.5% in the placebo group and 2.8% in the motavizumab group; p<0.001), Treatment was well tolerated, with adverse events similar between the treatment and placebo arms. Based on the results Med Immune plans to move forward with the development of motavizumab.

May 8, 2006

Alnylam reported positive results of a pair of phase I trial of ALN-RSV01, for the treatment of respiratory syncytial virus infections at the 2006 Pediatric Academic Societies' Annual Meeting in San Francisco. The double-blind, placebo-controlled, randomized studies enrolled a combined 101 subjects (34 in the US, 67 in Europe), who received single (1.5, 5, 15, 50, or 150 mg) or multiple (5, 25, and 150 mg daily for 5 days) doses of the drug or saline placebo via nasal spray. Primary safety data were generally positive, with no serious adverse events reported and an overall adverse event rate comparable to placebo. No evidence of laboratory abnormalities or electrocardiographic complications was noted. Pharmacokinetic data indicated no significant systemic exposure to the drug following intranasal administration.

Human Genome Sciences issued interim results of an ongoing phase II trial of Albuferon, for the treatment of treatment-experienced HCV infections. This randomized study had treated 71 patients to date, who received one of three doses of Albuferon (900 mcg every 14 days, 1200 mcg every 14 days, or 1200 mcg every 28 days) plus weight-based oral ribavirin (500 mg or 600 mg twice daily). 63% (n=45/71) of subjects had previously now responded to treatment with pegylated interferon alpha, and 93% (n=66/71) were infected with genotype 1 HCV. Pooled trial data indicated that 31% (n=22/71) of subjects (all treatment groups) achieved undetectable HCV RNA load at 48 weeks. Follow-up data from 12 weeks after the conclusion of treatment indicated that 20% of subjects maintained undetectable HCV RNA levels. Antiviral activity was similar between the 14 and 28 day 1200 mcg groups.

Pharmasset and Bukwang announced preliminary results pf a phase III trial, dubbed Study 303, of clevudine for the treatment of hepatitis B (HBV) infections. This late-stage study had treated 55 treatment-naïve patients to date at sites in Korea; 40 subjects were hepatitis B e antigen positive (HBeAg+) and 15 were HBeAg-. All subjects received 30 mg of the drug daily for 24 weeks, followed by 10 mg daily for a 24-week maintenance period. At 48 weeks 68% of HBeAg+ and 100% of HBeAg- patients achieved HBV DNA levels <300 copies/ml (PCR negative), and 89% and 100% of patients (respectively) achieved normal alanine aminotransferase levels (a measure of liver function). Further 16% experienced loss of serum HBeAg, and HBeAg seroconversion occurred in 14% of HBeAg+ patients. No serious adverse events were reported.

Roche issued positive results of a phase I trial of R1626, for the treatment of hepatitis C (HCV) infections. This randomized, placebo-controlled study had enrolled 18 subjects to date, who received one of two doses of the drug (500 mg or 1500 mg) or placebo twice daily for 14 days, with a 14 day follow-up. This higher trial dose produced a mean reduction in serum HCV RNA level of 1.2 log10, a clinically significant result. Both doses of the drug were well tolerated, with no serious adverse events reported and no early withdrawals from the trial. The trial was ongoing, including higher dose regimens of the drug.

July 12, 2004

Arrow Therapeutics have announced positive results of their phase I safety and tolerability trial of A-60444, their investigational antiviral drug for the treatment of Respiratory Syncytial Virus infection. The trial found the drug to be safe and well tolerated. The trial, which enrolled healthy individuals in the UK, investigated the tolerability and pharmacokinetic profile of oral administration of A-60444. No serious adverse events were reported, and pharmacokinetic analysis of the drug indicated that once daily dosing appears feasible. Arrow is pursuing AD-60444 for RSV in both pediatric and immune-compromised-adult populations (current therapies are only approved for premature and high-risk infants). The company has announced plans to initiate phase II trials in the second half of 2004.

October 28, 2002

MedImmune reported a large, multinational phase III trial investigating Synagis, was safe and effective in preventing respiratory syncytial virus (RSV) related hospitalizations in young children with congenital heart disease (CHD). The four-year study, beginning in 1998, was conducted at 76 sites in the U.S. and Europe. Designed to assess the safety and efficacy in children under two, the study randomly injected 1,287 subjects with either Synagis or placebo during the RSV season. Compared to placebo, the Synagis group had 45% fewer hospitalizations due to RSV. The data showed there were significantly fewer RSV-related hospital days and fewer days of increased oxygen usage in the treatment group than in the placebo group. Similar proportions of subjects in the placebo and Synagis groups experienced adverse events.

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